Delcath Systems Financial Review and Outlook

Delcath Systems, Inc. (NASDAQ: DCTH), is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Commercial activities have been taking place in the Europe segment. Delcath is still in the late stage clinical development in the US. Presently it generates revenue from its reimbursement program. Delcath has identified the potential markets with large global patient population of 1.2 million patients diagnosed annually.

In the recent past, the company has made headlines for reasons other than its core development pipeline. Delcath shares has been in continuous action after its shareholders voted down a reverse split. As a result of the shareholders non-approval of its reverse stock split last week by the requisite vote required under Delaware law, the Company does not meet the requirements for continued listing on the Nasdaq Capital Market.

Delcath had decided on the reverse stock split so that it could issue new shares to raise funds for the Company’s day-to-day operations, support clinical programs, amortization of its Convertible Notes and to avail equity financing. The Company had reached the maximum number of authorized shares of common stock under its Certificate of Incorporation. The Company needed additional authorized shares to arrange for equity financing and access approximately $11.8 million in cash which was blocked in the Convertible Notes issued in 2016. The reverse split would have reduced the number of shares and hence allow the Company to issue new shares for raising funds. The second reason for the reverse stock split was to comply with NASDAQ Capital Markets’ continued-listing requirements.

Subsequently, the decision to delist from NASDAQ was taken following the Company’s review and consideration of several factors including the likelihood of ongoing non-compliance with the NASDAQ listing requirements. The Board of Directors determined that an orderly transition to the OTCQB is in the best interests of the Company and its shareholders.

DCTH recently announced that after conversations with both Nasdaq and OTC Markets, the Company is able to effect the change in listing to the OTC Markets more quickly than anticipated. The Company’s common stock will commence trading on the OTCQB on or about September 22, 2017 under the symbol “DCTH”.

Notwithstanding these developments, Delcath’s oncology platform continues to remain robust and therefore it should not have troubles picking up an associate/strategic partner, with which it can push forward its product platform. The company must issue its common shares to fund its operations and support its clinical programs.

The Company reported its second quarter result on August 2nd; During the first half of 2017 it continued to advance its clinical development programs in ocular melanoma liver metastases (OM) and intrahepatic cholangiocarcinoma (ICC), while making steady progress with the ongoing commercialization of CHEMOSAT in Europe.

Revenues for the second quarter of 2017 increased 20% from a year ago, demonstrating continued growing demand in core markets. This increase is largely driven by the recent establishment of ZE diagnostic-related (DRG) reimbursement for CHEMOSAT in Germany.

DCTH continues to leverage this positive German reimbursement to support its efforts to obtain market access and payment in other markets such as the U.K. and the Netherlands, where there is growing interest in and use of CHEMOSAT. This is evidenced by the recent inclusion of CHEMOSAT in the Dutch Health Authorities treatment guidelines for ocular melanoma liver metastases, an important step toward eventual reimbursement coverage of CHEMOSAT in the Dutch market.

Outlook over the medium term: For rest of 2017, the company plans to focus on advancing its clinical programs of its innovative Melphalan/HDS, as well as to push commercialization efforts for CHEMOSAT in Europe. DCTH continues its focus on the clinical trials that comprise Clinical Development Program (CDP). Its CDP consists of its FOCUS Phase 3 clinical trial of Melphalan/HDS in hepatic dominant OM (the FOCUS trial) and its intrahepatic cholangiocarcinoma (ICC) pivotal trial, which is scheduled to initiate enrollment by the end of 2017.

To be looking at a company in this position, with the dust settled and clarity on way forward, Delcath is in a very attractive position. Furthermore, Delcath’s development program continues to looks promising. Analysts covering the stock are projecting that the stock will reach $4 within the next 52-weeks.

Description: Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers.

Major product pipeline:

Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) – is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.

DCTH has commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the fall of 2017. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.

In Europe, the company’s system has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT has been included in Dutch Health Authorities Guidelines (published in July 2017) as a recommended treatment for ocular melanoma liver metastases.

Successful and positive outcome of the near/medium term catalyst (mentioned above) would lead the future direction for DCTH. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.

DCTH’s operations are still at a nascent stage and have not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor. Moreover, meaningful commercialization of its upcoming products candidates is not likely to happen in the near future.

As of June 30, 2017, Delcath had cash and cash equivalents of $1.8 million. It is highly likely that it could raise cash over the medium term. That means investors should expect dilution after the next round of funding.

Earnings Review:

Revenue for the second quarter of 2017 was $0.6 million, an increase of 20% from $0.5 million for the second quarter of 2016. Total operating expenses for the current quarter were $5.0 million compared with $4.2 million in the prior-year quarter.

The Company recorded a net loss for the three months ended June 30, 2017, of $2.0 million, a decrease of $4.7 million, or 70.9%, compared to a net loss of $6.7 million for the same period in 2016.

As of June 30, 2017, Delcath had cash and cash equivalents of $1.8 million, compared with $4.4 million as of December 31, 2016. In addition, the Company has $12.9 million in restricted cash primarily related to the Convertible Notes issued in June 2016.

Stock Performance:

On Friday, September 15th, 2017, DCTH shares closed at $0.082. Market capitalization is $49.85 million. The current RSI is 37.82

In the past 52 weeks, shares of DCTH have traded as low as $0.01 and as high as $4.70

At $0.08, shares of DCTH are trading below their 50-day moving average (MA) at $0.123 and below their 200-day MA at $0.304

The present support and resistance levels for the stock are at $0.0747 and $0.0897 respectively.

Our track record speaks for itself…

Traders News Source recent profiles and track record, 368% in verifiable potential gains for our members on 3 small cap alerts alone! These are just three examples from over two dozen winners this year. We have had the #1 gainer on the entire NASDAQ exchange 8 times this year so far and one that was the #1 gainer on the exchange two days in a row (NASDAQ: SPEX).

May 23rd, 2016- (NYSE: XXII) opened at $.87/share hit a high of $3.03/share so far our member potential gains- 248% – http://mailchi.mp/tradersnewssource/updates-5-of-our-profiles-for-212-400-and-whats-coming-next?e=[UNIQID]

These are numbers that make traders drool. Any trader in any market would fall all over themselves to see numbers like this. So, if you’ve been on the fence, perhaps it’s time to start doing some research and verify our numbers for yourself. We are constantly raising the bar and separate ourselves from the rest of the small-cap newsletters as the best in business.

We know with a large following comes a large responsibility as we have everyone from institutional investors to the beginner following our profiled securities in our newsletters. This is something we take very seriously always seeking small cap growth companies that have both near and long-term potential for our members.

Big Opportunities Trading Small Cap Stocks

***Get our small cap profiles, special situation and watch alerts in real time. We are now offering our VIP – SMS/text alert service for free, simply text the word “Traders” to the phone number “25827” from your cell phone***

Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.

This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.

We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.

When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.

17B Disclosure

Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.

PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.

Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.

TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.

The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.

Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.

About Us

Created for active traders, Traders News Source is dedicated to being your number one source of breaking market news. Not only do we bring you top stories in key sectors, we give you well-researched expert reviews of specific opportunities in hot sectors like biotech, energy, new technology and more.